Public Interest Organizations and the 2016 Special 301 : An Indian Perspective

As promised, in this post I’ll highlight the treatment meted out to the comments and testimonies of the public interest organizations in the Report (only general and India specific comments). The public interest organizations which submitted written comments to the USTR were –

Barring the Colombian Civil Society Organizations, these organizations had also testified before the USTR. ( See here for the details on the public hearing)

UACT’s Written Submission and Testimony :

Recognizing India’s importance for its efficient supply of affordable generic drugs, the UACT severely objected to PhRMA’s misrepresentation of the WTO rules on issuance of compulsory license (CL) during national emergency. As expected, the Report took a dig at India’s CL law even though in recent times only one CL was issued. A rather oddity considering its repeated emphasis upon U.S.’s commitment to the Doha Declaration on the TRIPS Agreement and Public Health.

Further, a request for conducting a period impact assessment study on the implications of the IPR policies endorsed by it (through the Special 301) on patients and their families was made. It specifically called for statistics illuminating the number of cancer deaths due to lack of affordable generic drugs which were otherwise accessible via compulsory license had it not been for USTR’s pressure. The Report is silent on the status of this request.

KEI’s Testimony :

Highlighting India’s strategic importance in the access to affordable medicare debate, it called for a a policy coherence between human rights and innovation. Paradoxically, on one hand, the Report affirms U.S.’s commitment to the Doha Declaration and on the other takes a dig at policies facilitating accessibility to affordable medicines.

Some excerpts highlighting this paradox are –

The United States also recognizes the role of IPR protection in the development of new medicines, while being mindful of the effect of IPR protection on price.

The United States is firmly of the view that international obligations such as those in the TRIPS Agreement have sufficient flexibility to allow trading partners to address the serious public health problems that they may face. Consistent with this view, the United States respects its trading partners’ rights to grant compulsory licenses in a manner consistent with the provisions of the TRIPS Agreement and the Doha Declaration on the TRIPS Agreement and Public Health, and encourages its trading partners to consider ways to address their public health challenges while also maintaining IPR systems that promote innovation.

While emphasizing our continued commitment to the Doha Declaration on the TRIPS Agreement and Public Health, (see Intellectual Property and Health), the United States also continues to monitor India’s application of its compulsory licensing law. The United States requests clarity from the Government of India regarding the compulsory license decision-making process, as it affects U.S. stakeholders…..Although the government has issued only one compulsory license under Section 84 of India’s Patents Act and recently rejected another Section 84 petition, India has made clear in other policy statements that it views compulsory licensing as an important tool of industrial policy for green technologies, with the potential to be applied more regularly across economic sectors

Similar paradox is visible in its assessment of Section 3(d) of the Indian Patent Act, 1970.

Public Citizen’s Testimony :

Burcu Kilic of the Public Citizen opined on the ambit of the Report. She remarked that the Special 301 should solely address IP. Ancillary public policies such as pharmaceutical reimbursement, pricing or procurement should be outside its purview. However, the Report mentions them extensively as a market access barrier. (See pages 23 and 44)

As per her testimony, criticism of a country’s IP policies should be accompanied by a clearly articulated criteria. This has found favor in the Report atleast with respect to India. Issues highlighted are akin to objections rather than criticisms.

A statement on Section 3(d) and India’s CL law duly complying with TRIPS was made. She viewed that any reference to Section 3(d) in the Report must be considered in its full context if it is to provide any informative value. Unfortunately, the Report’s reference to Section 3(d) is bereft of any contextual analysis and can be best described as tendentious.

On the coherence between TRIPS flexibilities and Section 3(d), the USPTO questioned whether under any situation a new form, a new formulation or a new structure could be patentable subject matter. She indicated that the real problem was the seeking of second rate patents. To my dismay, this problem finds no place in the Report.

A question on Public Citizen’s position on ancillary public policies such as pharmaceutical pricing and reimbursement policies was raised by the Department of Health and Human Services. She exhorted that those policies did not suffice as IP. Their primary concern being drug pricing, which is extensively mentioned in the Report as a market access barrier.

PJIIP’s Written Submission and Testimony :

Underscoring the importance of limitations and exceptions, it advocated for the benefits emanating from a liberal construction of the fair use exception. However, this has not found place in the Report.

Inapplicability of India’s fair dealing provision to sound recordings and cinematographic films was also expressed as an area of concern. Objections on Indian Performance Rights Society’s unclear jurisdiction, rights and limitations was also raised. Neither of these have been mentioned in the Report. USTR refrained from commenting on the fair dealing provision. This could be due to its hesitation to subvert the mandate of the Special 301.(For more on this, see my post here).

Responding to USTR’s question (on listing countries identified by it in the Report), it called upon the discretionary areas of the Reportto highlight the positive developments on limitations and exceptions as well. Discretionary areas of the Report are, “Positive Developments” and “Best IPR Practices“. Neither of these sections have accommodated this request.

CONCLUSION :

In past, there’ve been reports on the public interest organizations being subjected to an onerous burden of proof vis – a- vis trade groups (see here, here and here). However, this year, a parity atleast at that front has been maintained. Both categories of organizations were asked almost the same number of questions (between 2-3), with the USTR even commending PIJIP for its work. Even the difficulty level of the questions raised was the same.

Despite this, the meek deference given to the recommendations of the public interest organizations in the Report is an unfortunate missed opportunity.

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